FDA.reportPublic FDA data

GAMBRO

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96102703012394756GAMBRO DASCO S.P.A., BLOOD LINE DIVISION1N2026-01-01VIA MODENESE, 66 MEDOLLA Modena IT 41036
96113693002807035GAMBRO DIALYSATOREN GMBH1N2026-01-01HOLGER - CRAFOORD - STRASSE 26 HECHINGEN Baden-Wurttemberg DE 72379
30035046043003504604Gambro UF Solutions LLC1N2026-01-011405 Xenium Ln N, Suite 150 Plymouth MN US 55441
30043670283004367028GAMBRO KATHETERTECHNIK HECHINGEN1N2020-04-25LINSENAECKER 1 HECHINGEN Baden-Wurttemberg DE DE-72379
30065526113006552611Gambro Renal Products, Inc.1N2020-04-251101 Jeter Avenue Opelika AL US 36801
30076978643007697864Gambro Rostock GmbH1N2020-04-25Friedrich Barnewitz-Str.3 Rostock Mecklenburg-Vorpommern DE 18119

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
07332414102500Ultrafilter U 9000 - The U9000 Ultrafilter is indicated for purification of incoming water for dialysis fluid as well as purification of dialysis fluid to obtain microbiological high quality dialysis fluid. The risk of exposure to bacteria and endotoxins can thereby be minimized.+1(800)933-0303medinfo_medproducts@baxter.com
07332414121594NA - NA - Accessory Drain Bag (5L); Accessory for hemodialysis+1(800)933-0303medinfo_medproducts@baxter.com
07332414124519AK 98 - Intended for intermittant haemodialysis and/or isolated ultrafiltration treatments. Indicated to be used on patients with a body weight of 25 kg or more. To be used by trained operators in chronic care dialysis or hospital care environment. Not intended for Self-care or Home use.+1(800)933-0303medinfo_medproducts@baxter.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1288221625554406K923065BAXTER PERSONAL CYCLER AUTOMMATED PERITONEAL DIALFKX1994-03-04
186001634180848K873643GAMBRO ADSORBA 150CFLD1987-12-29
185971277847247K823707HOSPAL BLOOD LINESKOC1983-01-05
1288221323811582K791899CYCLER SETS MOD. #5C4143, 5C4144, 5C4145KDJ1979-11-13
185971418252250K232467CleanCart A, CleanCart C, AK 98 Hemodialysis MachineKDI2023-09-14
1288221920041302K231849MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483KDJ2024-03-12
1288221506618409K21401615L Cycler Drainage BagKDJ2022-03-18
186001673036134K213639Revaclear 500, Revaclear 400, Revaclear 300KDI2022-01-24
186001445837300K211035U9000 Plus UltrafilterFIP2021-10-19
186001483072827K201809AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber AccessoryKDI2021-03-10
185971483072827K201809AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber AccessoryKDI2021-03-10
1288221997992711K193482PrisMax System Version 3KDI2020-03-13
1288221019299460K190910PrisMax System Version 2KDI2019-07-25
1288222073643942K163530PrisMax Control UnitKDI2017-05-03
1288221853369401K152129FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine SolutionKDJ2015-10-29
1288221945361280K151525Amia Automated PD System with SharesourceFKX2015-10-09
186001848042131K133807MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNITFLD2014-03-26
1036461848042131K133807MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNITFLD2014-03-26
186001142140372K130039REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZERKDI2013-05-02
878881142140372K130039REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZERKDI2013-05-02
1036461301746045K113313MOLECULAR ADSORBENT RECIRCULATING(MARS)FLD2012-12-14
1288221157075144K102936HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310RFKX2011-03-30
185971157075144K102936HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310RFKX2011-03-30
186011208426577K100451GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132MPB2010-12-21
185971167149329K072908PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPYKPO2008-02-04
878881312424068K072232GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALLKDI2007-09-07
878882027047716K060195GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USEKDI2006-04-24
186001032695987K051520GAMBRO POLYFLUX HEMODIALYZER, MODEL 6HKDI2005-12-09
186002071852981K043342POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LRFJI2005-05-27
185971563847749K013724BICARTKPO2002-01-08
1288221262518114K012988HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469FKX2001-12-05
186001619075872DEN190042Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 DialyzerQAX2020-08-28
186001045741721
186011484839969
1288221126104761
1288221181136568
185971181136568

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KDI122023-09-14
FKX52015-10-09
KDJ42024-03-12
FLD42014-03-26
KPO32008-02-04
FIP12021-10-19
QAX12020-08-28
MPB12010-12-21
FJI12005-05-27
KOC11983-01-05

PMA#

PMN#

BICART

2002-01-08

GAMBRO RENAL PRODUCTS

143 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next